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510(k) K052947

SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE by Source Production & Equipment Co., Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2006
Date Received
October 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

Other clearances by Source Production & Equipment Co., Inc.

  • K162573 — Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Sourc (November 4, 2016)
  • K161396 — SPEC Model M23 (August 17, 2016)
  • K161395 — SPEC Model M13 (July 6, 2016)
  • K150895 — SPEC Model M16 (June 19, 2015)
  • K132969 — SPEC MODEL M15 (January 2, 2014)
  • K090366 — SPEC MODEL M-31 (April 22, 2009)

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